Method and instruments for inserting modular implant components

ABSTRACT

An instrument is disclosed for inserting a modular implant, the instrument comprising a first end and a second end, the first end having engagement means for engaging a stem component of the modular implant, the engagement means comprising separation means for separating a body component of the modular implant and the stem component from one another so as to permit rotational positioning of the body component and the stem component relative to one another.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

[0001] This patent application claims benefit of pending prior U.S. Provisional Patent Application Serial No. 60/378,986, filed May 9, 2002 by Steven C. Pubols et al. for METHOD FOR INSERTING MODULAR IMPLANT COMPONENTS, which patent application is hereby incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This invention is related to modular orthopedic apparatus and methods in general, and more particularly to apparatus and methods for inserting modular implant components.

BACKGROUND OF THE INVENTION

[0003] The aim of Total Hip Arthroplasty (THA) is the reduction of pain and the restoration of function to a diseased hip joint via the substitution of engineered materials for the diseased tissue. Successful outcomes depend largely on the proper sizing, placement and orientation of the implant. Incorrect biomechanics (e.g. joint reaction forces, soft tissue balancing) can slow or prevent healing, cause gait abnormalities and lead directly to early implant failure.

[0004] There are three portions to the femoral side of a total hip prosthesis: the neck, body, and stem. In a one piece hip design, all three of these portions are a part of a solid construct. As a solid construct, the orientation of each portion with respect to one another is fixed and unchangeable. A surgeon implants one of these solid construct devices by attaching a handle or holder to the prosthesis and then driving it into a prepared opening in the bone. The orientation of the neck and stem is controlled by, and limited to, the orientation of the prepared opening in the bone.

[0005] With the invention of two-piece designs, specifically U.S. Pat. No. 4,846,839, issued to Noiles, incorporated herein by reference, and subsequently marketed and sold by DePuy, A Johnson and Johnson Company, under the “S-ROM Hip System” tradename, a surgeon is given the opportunity to independently orient the position of the implant body apart from the rotation or anteversion of the neck. In these designs, the stem and neck of the implant are a one-piece component and the body of the implant is a separate component. These devices also incorporate flutes or spines on the stems of the implant so as to provide additional resistance to rotation. These spines engage the bone during the initial few inches of insertion into the femoral canal, forcing the final location of the implant neck to be totally dependent on the initial insertion orientation of the distal stem. If the stem is fully inserted and the neck is incorrectly oriented, the entire implant must be removed, indexed, and reinserted. This iterative approach to neck placement is time consuming, damages the bone/implant interface, and results in the loss of implant stability. This problem is compounded when a bowed stem is used in place of a straight stem. The bow in the stem will follow the natural bend in femoral canal, which in turn dictates the final position of the femoral neck. Using two-piece modular implants, where the first piece is a neck with curved stem component and the second piece is the body component, a surgeon is given no choice or option for the femoral neck orientation with respect to the orientation of the bowed or curved stem.

[0006] With a three-piece modular implant, there is provided a stem component, a neck component, and a body component which are independent of one another and are independently adjustable with respect to one another. With insertion, the stem component and body component each seek a best fitting position within the femoral canal. Following insertion, the neck component can be oriented by a surgeon in order to establish optimal joint and motion mechanics.

[0007] Prior to insertion of an actual implant, the use a mock implant or “trial” is desirable as a means of evaluating correct size and positioning. A surgeon uses the measurements taken from the trial implant so as to select the final implant components. A trial stem is generally smaller than an implant stem and is configured without spines or flutes so as to aid in the insertion and removal of the trial without damaging the bone/implant interface. When inserted into the prepared cavity in the bone, the stem component will follow the path of least resistance so long as its motion is not restricted otherwise. For this reason, it is advantageous to allow the implant stem rotational freedom with respect to the body when inserting the final implant. Although it is desirable for the stem component to be rotationally free during insertion, it is important for the stem component to be properly aligned with the body and neck components so as to ensure proper final assembly. Without this alignment, the stem may be off axis, making it difficult or impossible to assemble the neck and body segments along an axis.

[0008] Other methods for implanting two-piece or three-piece modular devices where the stem component is separate from the body and/or neck component(s) include inserting the stem component until it is proud of its intended final position and then using the body component to seat the stem by impaction. For example, a two-piece system having separate stem and combination body/neck components is manufactured and sold by the Biomet Corporation, under the “Impact Hip System” tradename. For further example, a three-piece system having separate stem, body, and neck components is manufactured and sold by the Exactech Corporation, under the “Accumatch M-Series Hip System” tradename. In both examples, impaction of the body onto the stem also serves to secure the stem and body assembly. One disadvantage of this method is that stem/body orientation must be determined visually prior to full seating and may shift during implantation. Another disadvantage is that the assembly force is equivalent to the resistance of the stem sliding down the canal. If the stem moves in the canal during final assembly, the stem may be driven too deeply into the canal causing surgical delays, or the stem and body will not be tightly assembled, leading to fretting, corrosion, and early failure of the construct.

SUMMARY OF THE INVENTION

[0009] An object of the invention is to provide an instrument for inserting a modular implant in which the instrument allows the rotational positioning of the body component, neck component and stem component relative to one another.

[0010] Another object of the invention is to provide an instrument for inserting a modular implant which allows rotational positioning of a neck and body component relative to a stem component.

[0011] A further object of the invention is to provide a system for inserting a modular implant in which the insertion tool provided with the body component and the stem component allows positioning of the body component and the stem component relative to one another.

[0012] With the above and other objects in view, as will hereinafter appear, there is provided an instrument for inserting a modular implant, the instrument comprising a first end and a second end, the first end having engagement means for engaging a stem component of the modular implant, the engagement means comprising separation means for separating a body component of the modular implant and the stem component from one another so as to permit rotational positioning of the body component and the stem component relative to one another.

[0013] This invention provides for an improved apparatus and method of inserting or implanting a modular orthopedic prosthesis. The improved apparatus and method allows the components of the implant to be assembled together and inserted into the femur without the need for the modular connections to be locked together, thereby permitting each component to seek its best fitting position within the canal. Further, this permits the orientation of the neck component relative to the body and stem after they have achieved this best fitting position. The implant neck, body, and stem may rotate freely with respect to one another until the components are fully seated in the bone. The results in improved alignment between the implant and the bone, which in turn reduces the time and force required to implant the prosthesis. For example, this method may be used in implanting hip, shoulder, and knee prostheses.

[0014] In accordance with a further feature of the invention there is provided a system for inserting a modular implant, the system comprising: a body component having a neck segment extending therefrom, and the body component forming a bore and counterbore therein; a stem component having a threaded end configured for selective disposal within the bore and counterbore so as to expose through the counterbore a given length thereof; and an insertion tool comprising a first end and a second end, the first end forming a threaded recess for engaging the stem component of the modular implant, the threaded recess having a depth less than the length of the threaded end so as to permit rotational positioning of the body component and the stem component relative to one another.

[0015] The present invention improves upon existing techniques by allowing for the complete (fully seated) implantation of the stem and body while maintaining rotational freedom between the stem, body, and neck components. Alternatively, the surgeon may elect to assemble the neck and body at the desired orientation as determined during the trialing phase of surgery. A method of a preferred embodiment of the present invention allows for the stem to be held securely during insertion, while the neck and body assembly may rotate freely about the stem positioning in order to seat the stem in a best fitting position. Once the body is fully seated, the driver may be removed and the implants may be fully assembled using an assembly tool or another instrument. The present invention is not limited to the use of three-piece designs. The present invention may be used in a two-piece design where the neck and body portions of the implant are manufactured as a one-piece component.

[0016] The above and other features of the invention, including various novel details of construction and combinations of parts and method steps will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular devices and method steps embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:

[0018]FIG. 1 is a schematic illustration of one form of a modular implant system including a modular implant and an insertion tool; and

[0019]FIG. 2 is a schematic illustration of another form of a modular implant system including a unitary body/neck component for use with the insertion tool.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Referring to FIG. 1, and in a preferred embodiment of the present invention, there is shown a three-piece modular implant system 1. This three-piece modular implant of modular implant system 1 comprises a body segment 2, a neck segment 3 with a counterbore 4, and a stem segment 5 with a threaded end 6 and a taper 7. Threaded end 6 has a length to extend above the surface of counterbore 4 by a predetermined distance. Modular implant system 1 further comprises an insertion tool 8 with threaded hole 9. Hole 9 has a shorter depth than the predetermined distance of threaded end 6 extending above the surface of counterbore 4. Accordingly, when insertion tool 8 is threaded onto threaded end 6 a gap remains between the proximal surface of counterbore 4 and the distal end of insertion tool 8. When the proximal end of insertion tool 8 is impacted, taper 7 is forced out of engagement with the mating surface of body segment 2 so that neck segment 3 remains rotationally free.

[0021] In another preferred embodiment of the present invention (FIG. 2) there is provided a unitary component comprising a modular body/neck component 10 and a modular stem component 5. 

What is claimed is:
 1. An instrument for inserting a modular implant, the instrument comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of a modular implant and a body engagement feature for engaging a body component of a modular implant, the stem engagement feature and the body engagement feature being so disposed as to maintain a separation between an implant body component and an implant stem component when the engagement features are in contact with their respective components so as to permit rotational positioning of the body component and the stem component relative to one another
 2. An instrument for inserting a modular implant according to claim 1 wherein the second end of the instrument has an impaction site, and further wherein the body component and the stem component are disengaged from one another by applying a force to the impaction site.
 3. An instrument for inserting a modular implant according to claim 1 wherein the stem engagement feature comprises a threaded recess and one end of the stem component comprises a threaded end, the threaded end and the threaded recess configured to threadably engage one another, where the depth of the stem engagement feature is less than the length of the threaded end of the stem that is exposed above the engagement surface on the body when the implant is assembled together.
 4. An instrument for inserting a modular implant according to claim 1 wherein the stem engagement feature comprises a threaded protrusion and one end of the stem component comprises a threaded recess, the threaded recess and the threaded protrusion configured to threadably engage one another, where the length of the stem engagement feature is greater than the depth of the engagement surface on the stem below the engagement surface on the body when the implant is assembled together.
 5. An instrument for inserting a modular implant according to claim 1 wherein the stem engagement feature and the body engagement feature act to align the implant body and implant stem.
 6. An instrument for inserting a modular implant, the instrument comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of a modular implant and a neck engagement feature for engaging a neck component of a modular implant, the stem engagement feature and the neck engagement feature being so disposed as to maintain a separation between an implant neck component and an implant stem component when the engagement features are in contact with their respective components so as to permit rotational positioning of the neck component and the stem component relative to one another
 7. An instrument for inserting a modular implant according to claim 6 wherein the second end of the instrument has an impaction site, and further wherein the neck component and the stem component are disengaged from one another by applying a force to the impaction site.
 8. An instrument for inserting a modular implant according to claim 6 wherein the stem engagement feature comprises a threaded recess and one end of the stem component comprises a threaded end, the threaded end and the threaded recess configured to threadably engage one another, where the depth of the stem engagement feature is less than the length of the threaded end of the stem that is exposed above the engagement surface on the neck when the implant is assembled together.
 9. An instrument for inserting a modular implant according to claim 6 wherein the stem engagement feature comprises a threaded protrusion and one end of the stem component comprises a threaded recess, the threaded recess and the threaded protrusion configured to threadably engage one another, where the length of the stem engagement feature is greater than the depth of the engagement surface on the stem below the engagement surface on the neck when the implant is assembled together.
 10. An instrument for inserting a modular implant according to claim 6 wherein the stem engagement feature and the neck engagement feature act to align the implant neck and implant stem.
 11. An instrument for inserting a modular implant, the instrument comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of a modular implant and a main implant engagement feature for engaging a main implant component of a modular implant, the stem engagement feature and the main implant engagement feature being so disposed as to maintain a separation between an implant main implant component and an implant stem component when the engagement features are in contact with their respective components so as to permit rotational positioning of the main implant component and the stem component relative to one another
 12. An instrument for inserting a modular implant according to claim 11 wherein the second end of the instrument has an impaction site, and further wherein the main implant component and the stem component are disengaged from one another by applying a force to the impaction site.
 13. An instrument for inserting a modular implant according to claim 11 wherein the stem engagement feature comprises a threaded recess and one end of the stem component comprises a threaded end, the threaded end and the threaded recess configured to threadably engage one another, where the depth of the stem engagement feature is less than the length of the threaded end of the stem that is exposed above the engagement surface on the main implant when the implant is assembled together.
 14. An instrument for inserting a modular implant according to claim 11 wherein the stem engagement feature comprises a threaded protrusion and one end of the stem component comprises a threaded recess, the threaded recess and the threaded protrusion configured to threadably engage one another, where the length of the stem engagement feature is greater than the depth of the engagement surface on the stem below the engagement surface on the main implant when the implant is assembled together.
 15. An instrument for inserting a modular implant according to claim 11 wherein the stem engagement feature and the main implant engagement feature act to align the implant main implant and implant stem.
 16. A method for inserting a modular implant, the instrument where: an instrument is provided comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of a modular implant and a body engagement feature for engaging a body component of a modular implant, the stem engagement feature and the body engagement feature being so disposed as to maintain a separation between an implant body component and an implant stem component when the engagement features are in contact with their respective components so as to permit rotational positioning of the body component and the stem component relative to one another
 17. A method for inserting a modular implant according to claim 16 wherein the second end of the instrument has an impaction site, and further wherein the body component and the stem component are disengaged from one another by applying a force to the impaction site.
 18. A method for inserting a modular implant according to claim 16 wherein the stem engagement feature comprises a threaded recess and one end of the stem component comprises a threaded end, the threaded end and the threaded recess configured to threadably engage one another, where the depth of the stem engagement feature is less than the length of the threaded end of the stem that is exposed above the engagement surface on the body when the implant is assembled together.
 19. A method for inserting a modular implant according to claim 16 wherein the stem engagement feature comprises a threaded protrusion and one end of the stem component comprises a threaded recess, the threaded recess and the threaded protrusion configured to threadably engage one another, where the length of the stem engagement feature is greater than the depth of the engagement surface on the stem below the engagement surface on the body when the implant is assembled together.
 20. A method for inserting a modular implant according to claim 16 wherein the stem engagement feature and the body engagement feature act to align the implant body and implant stem.
 21. An instrument for inserting a modular implant, the instrument comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of the modular implant and a body engagement feature for engaging a body component of the modular implant, the second end having an impaction feature for applying a force to the instrument, the stem engagement feature and the body engagement feature being configurably disposed so as to maintain a separation between the body component and the stem component so as to permit rotational positioning of the body component and the stem component relative to one another.
 22. An instrument for inserting a modular implant according to claim 21 wherein the second end of the instrument has an impaction site, and further wherein the body component and the stem component are disengaged from one another by applying a force to the impaction site.
 23. An instrument for inserting a modular implant according to claim 21 wherein one end of the stem component comprises a threaded end extending from the stem component and the stem engagement feature forms a threaded recess, the threaded end and the threaded recess configured to threadably engage one another, wherein the distance between the stem engagement feature and the body engagement feature is less than the distance between the engagement surface on the stem and the engagement surface on the body when the implant is assembled together.
 24. An instrument for inserting a modular implant according to claim 21 wherein an end of the stem component comprises a threaded recess extending into the stem component and the stem engagement feature forms a threaded protrusion, the threaded recess and the threaded protrusion configured to threadably engage one another, wherein the distance between the stem engagement feature and the body engagement feature is greater than the distance between the engagement surface on the stem and the engagement surface on the body when the implant is assembled together.
 25. An instrument for inserting a modular implant according to claim 21 wherein the stem component comprises a threaded end extending therefrom and the stem engagement feature forms a threaded recess, the threaded end and the threaded recess configured to threadably engage one another, where the distance between the stem engagement feature and the body engagement feature is less than the distance between the engagement surface on the stem and the engagement surface on the body.
 26. An instrument for inserting a modular implant according to claim 21 wherein the second end of the instrument has an impaction site, and further wherein the body component and the stem component are disengaged from one another by applying a predetermined force to the impaction site.
 27. An insertion tool for inserting a modular implant according to claim 21 wherein the second end of the instrument has an impaction site, wherein the body component and the stem component are disengaged from one another by applying a predetermined force to the impaction site.
 28. An insertion tool for inserting a modular implant of the type comprising a body component having a neck segment extending therefrom, and the body component forming a bore and counterbore therein, and a stem component having a threaded end configured for selective disposal within the bore and counterbore so as to expose through the counterbore a given length thereof, the insertion tool comprising: a first end and a second end, the first end forming a threaded recess for engaging the stem component of the modular implant, the threaded recess having a depth less than the length of the threaded end so as to permit rotational positioning of the body component and the stem component relative to one another.
 29. An insertion tool for inserting a modular implant according to claim 28 wherein the body component comprises a unitary body segment and neck segment.
 30. An insertion tool for inserting a modular implant according to claim 28 further comprising a neck component configured to selectively attach to the body component.
 31. An instrument for inserting a modular implant, the instrument comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of the modular implant and a neck engagement feature for engaging a neck component of the modular implant, the second end having an impaction feature for applying a force to the instrument, the stem engagement feature and the neck engagement feature being configurably disposed so as to maintain a separation between the neck component and the stem component so as to permit rotational positioning of the neck component and the stem component relative to one another.
 32. An instrument for inserting a modular implant, the instrument comprising: a first end and a second end, the first end having a stem engagement feature for engaging a stem component of the modular implant and a main implant engagement feature for engaging the main component of the modular implant, the second end having an impaction feature for applying a force to the instrument, the stem engagement feature and the main implant engagement feature being configurably disposed so as to maintain a separation between the main implant component and the stem component so as to permit rotational positioning of the main implant component and the stem component relative to one another. 